{"id":2391207,"url":"https://alion.io/job/fsttechnical-validation-project-lead-documentation-audit-lead-fst-technical-services","title":"Validation Project Lead / Documentation Audit Lead - FST Technical Services","company":{"id":4419698,"name":"FST Technical Services","domain":"fsttechnical.com","url":"https://alion.io/company/fsttechnical","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"JazzHR","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Durham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":99000,"max_usd":200000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1562},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Office","optional":true},{"name":"SharePoint","optional":true}],"status":"live","first_seen_at":"2026-10-12T21:16:11Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-14T09:44:11Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Validation Project Lead / Documentation Audit Lead\n Major Pharmaceutical Facility Construction ProjectLocation: Durham, NC - FST Life Science office\nFST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a large pharmaceutical manufacturing facility construction project.\nThis role is responsible for establishing a standardized process for the validation of hygienic welding documentation (Isometrics) to ensure compliance with project specifications, applicable codes (e.g., ASME BPE), and industry best practices to support full traceability for hygienic systems..\nResponsibilities\nLead documentation audit activities to ensure full traceability of hygienic piping systems.\nManage schedule, priorities, milestones, and deliverables.\nAudit weld documentation packages for GMP and Good Documentation Practices (GDP) compliance.\nEnsure document traceability.\nCoordinate resolution of documentation deficiencies and quality observations.\nPartner with Construction Management, Fabricators and Client representatives.\nMaintain validation metrics and documentation status reports.\nMentor junior validation specialists and documentation specialists.\nRequired Qualifications\nBachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related technical discipline (or equivalent experience).\n8+ years of pharmaceutical validation, CQV, QA, or GMP documentation experience.\n3+ years leading validation documentation or CQV teams on large pharmaceutical capital projects.\nStrong knowledge of FDA cGMP regulations (21 CFR Parts 210 & 211).\nThorough understanding of Good Documentation Practices (GDP).\nExperience supporting Commissioning, Qualification & Validation activities.\nExperience preparing projects for client and regulatory audits.\nExcellent project management, organization, and communication skills.\nPreferred Qualifications\nExperience with Traceability Matrices, ALCOA+, Equipment & Utilities Installation Qualification, \nExperience with EIDA, Bluebeam, Microsoft Office and 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